FDA 510(k) Application Details - K110628

Device Classification Name	Monitor, Ultrasonic, Nonfetal   More FDA Info for this Device
510(K) Number	K110628
Device Name	Monitor, Ultrasonic, Nonfetal
Applicant	NEWMAN MEDICAL 5350 VIVIAN STREET UNIT C Arvada, CO 80002 US Other 510(k) Applications for this Company
Contact	SPENCER NEWMAN Other 510(k) Applications for this Contact
Regulation Number	892.1540   More FDA Info for this Regulation Number
Classification Product Code	JAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2011
Decision Date	05/12/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review